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    FDA's MedWatch Safety Alerts: August 2009

    continued...

    The products were sold in stores in California, Georgia, Illinois, Texas and Ohio.

    The risk: FDA laboratories have found that these products contain a drug ingredient of FDA-approved drugs for erectile dysfunction. The ingredient is not declared on the label, making these products unapproved drugs.

    The undeclared ingredients in these products may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels.

    Recommendations

    • Stop using these products immediately.
    • Contact your health care professional if you have experienced any problems that may be related to taking these products.
    • Contact Nature & Health at (714) 671-0016 or at sales@naturenhealth.com for information on returning the products for a refund.

    Recall: Infusion Sets Used With Insulin Pumps

    Quick-set infusion sets made by Medtronic Inc. that are used with MiniMed Paradigm insulin pumps have been recalled because the infusion sets may not allow the insulin pump to vent air pressure properly. An infusion set is a thin plastic tube used to deliver insulin from an insulin pump to a person with diabetes.

    Affected infusion sets have lot numbers starting with the number “8” and have one of these reference numbers:

    • MMT-396
    • MMT-397
    • MMT-398
    • MMT-399

    The lot number (for example, 8XXXXXX) is clearly marked on both the product box label and on each individual infusion set package.

    The risk: The infusion set may deliver too much or too little insulin and may lead to serious injury or death.

    Recommendations

    • Stop using “Lot 8” Quick-set infusion sets.
    • Return any affected infusion sets to the company, which will replace them at no additional charge. For more information, see Medtronic's Web page or call Medtronic at 800-345-8139.

    Recall: Stealth Chocolate and Stealth Vanilla Powdered Dietary Supplement

    The powdered dietary supplement, Stealth Chocolate and Stealth Vanilla, has been recalled because it may be contaminated with the bacteria Salmonella. The product, made by Vital Pharmaceuticals Inc., was distributed nationwide, including GNC Distribution Centers and the VPX Sports Distribution Center, as well as internationally.

    The powdered product is packaged in 5-pound blue plastic jars with a red band around the top and bottom of the jar. The label bears the brand name of VPX and STEALTH, Muscle Amplification Lean Mass Gainer, and the flavor Vanilla Blast or Chocolate Rush.

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